KRAS Mutation (Codons 12 & 13) Analysis in UAE AED 1,500

Executive Summary & Core Metrics

99.9% Diagnostic Sensitivity via ISO 15189:2022 Accredited Molecular Laboratory — PCR fragment analysis detects mutant allele fractions as low as 1% from FFPE tissue.
Secure Medical Courier Solid Tissue Specimen Retrieval — temperature-controlled logistics for archival paraffin block transport from any Dubai Healthcare City facility or participating hospital.
Post-Test Clinical Guidance: Telephonic interpretation with a molecular oncologist to explain actionable KRAS mutation status for anti-EGFR therapy planning.
Insurance Support: Direct billing verification via WhatsApp +971 54 548 8731 for pre-approved oncology panels.

Test Overview & Methodology

The KRAS Mutation (Codons 12 & 13) Analysis is a molecular diagnostic assay that identifies activating single-nucleotide variants in exon 2 of the KRAS oncogene. Detection of a mutation at codon 12 or 13 predicts resistance to anti-EGFR monoclonal antibodies (cetuximab, panitumumab) in metastatic colorectal adenocarcinoma, making this test a mandatory prerequisite before initiating targeted biologic therapy. The assay employs fluorescence-based PCR fragment analysis with sizing by capillary electrophoresis, delivering a definitive binary result — mutated or wild-type — within five working days from receipt of an adequate FFPE tissue block.

Test Attribute	KRAS Codons 12/13 Analysis (PCR Fragment Analysis)	Conventional Sanger Sequencing
Mutation Coverage	Codons 12 & 13 (exon 2) with 1% mutant allele frequency sensitivity	Full exon 2 but ~20% mutant allele fraction detection limit
Methodology	PCR fragment analysis (STR-based sizing) per CAP/ESMO molecular pathology guidelines	Dideoxy chain termination
Turnaround Time	5 working days from FFPE block receipt	7–10 working days
Sample Requirement	FFPE block with ≥10% tumour cellularity + pathology review form	FFPE block or purified genomic DNA

Physician Insight & Safety Protocols

"KRAS mutation testing is not simply a gatekeeper for anti-EGFR therapy; it defines the molecular subclass of colorectal adenocarcinoma. A wild-type result enables targeted biologic intervention, while a detectable mutation redirects the treatment strategy toward alternative kinase inhibitors or cytotoxic regimens. However, this biomarker must never be interpreted in isolation — the full histopathological, radiological, and clinical context must always govern the final therapeutic decision."

— Mr. Prabhakar Reddy Kalathoor, Specialist Diagnostic Radiology, DHA Registration ID: 61713011

Medication Safety Advisory

Do not alter or discontinue any prescribed oncology medication without consulting your treating physician

KRAS status guides but does not immediately mandate changes to active treatment. Abrupt cessation of antineoplastic agents while awaiting molecular results may lead to disease flare or rapid progression. All therapy modifications must be reviewed by a multidisciplinary tumour board.

Exclusion Criteria & Clinical Red Flags

Tissue block with less than 10% tumour content — elevated risk of false-negative result; re-biopsy is recommended if clinically feasible.
Specimen exposed to non-formalin fixatives or subjected to decalcification — DNA degradation may invalidate the assay.
Haemorrhagic or necrotic tissue cores that lack viable malignant cells — repeat sampling required.
Seek immediate emergency care if you experience new severe pain, unexplained haemorrhage, or signs suggestive of tumour lysis syndrome during the waiting period.

Patient FAQ & Clinical Guidance

1. How long after my biopsy will the KRAS result be available, and how does it influence my treatment timeline?

Answer: Once your FFPE tissue block arrives at our laboratory, the molecular analysis is completed within five working days. Your medical oncologist receives the result by the following Monday morning, enabling prompt integration into your treatment plan — typically before the next scheduled chemotherapy cycle.

2. What does a positive KRAS mutation result mean for my prognosis and treatment options?

Answer: A mutation in codon 12 or 13 indicates that your tumour is unlikely to respond to anti-EGFR monoclonal antibodies such as cetuximab or panitumumab. However, this does not preclude effective treatment; your oncologist will recommend alternative therapies including RAS-MEK pathway inhibitors, standard cytotoxic regimens, or clinical trial options best suited to your molecular profile.

3. Why must the test be performed on an archival tissue block rather than a blood sample or cytology slide?

Answer: This assay is validated exclusively on FFPE tissue sections with a minimum of 10% tumour cellularity. Liquid biopsy (circulating tumour DNA) is not certified for this specific codon-12/13 fragment analysis methodology under current DHA diagnostic standards. The paraffin block ensures adequate genomic material for high-sensitivity mutation detection.

UAE Regulatory & Data Privacy Adherence

Data Protection and Healthcare Compliance Framework

All molecular genetic data generated by this assay is processed in accordance with Federal Decree-Law No. 45 of 2021 on Personal Data Protection (PDPL) and Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields. Clinical safety and informed consent procedures adhere to Federal Decree-Law No. 4 of 2016 on Medical Liability. Testing is conducted at a DHA-licensed laboratory facility under continuous ISO 15189:2022 quality management oversight.

Clinical & Logistical Metadata

Test Name	KRAS Mutation (Codons 12 & 13) Analysis
Price (AED)	AED 1,500
Turnaround Time	5 working days from FFPE block receipt
Sample Type / Matrix	Formalin-Fixed Paraffin-Embedded (FFPE) Tissue Block — Archival Specimen; Secure Medical Courier Solid Tissue Specimen Retrieval required
Methodology Used	PCR Fragment Analysis (Fluorescence-Based Capillary Electrophoresis)
ICD-10-CM Code	C18.9
LOINC Code	21663-7
DHA Facility License & Laboratory Address	License No. 1143 — Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE

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